Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair

Pain Clinical Trial

Official title:

Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773851
• Other study ID #: KEK_11/05
• Status: Completed
• Phase: N/A
• Start date: April 2005
• Est. completion date: October 2008

Study information

• Verified date: November 2023
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means. Different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.

Description:

Ventral hernia repair is increasingly performed by laparoscopic means. While mesh ingrowth and shrink-age has been analysed in the experimental setting, there is scarce data available in humans. In addition, different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients.

Mesh shrinkage is assessed using two different techniques for fixation.

Blinded randomized trial using a Parietene composite mesh for laparoscopic ventral hernia repair. Patients with ventral hernias of no larger than 8 cm were assigned to either mesh fixation using transfacial nonabsorbable sutures or titan tacks. Primary endpoint was mesh migration, secondary endpoints were mesh shrinkage, surgical morbidity and pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with incisional hernia smaller than 8cm in diameter

• obtained informed consent

Exclusion Criteria:

• Pregnancy

• Residual intraperitoneal mesh

• contaminated abdominal cavity

• longterm use of corticosteroids and other immunosuppressive agents

• bodymass index > 45

• general contradictions for laparoscopy

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Pain
• Ventral Hernia

Intervention

Procedure:
• mesh fixation by transfacial sutures
mesh fixation by transfacial sutures
• mesh fixation by staples
mesh fixation by staples

Locations

Country	Name	City	State
Switzerland	Dep. of Visceral and Transplantsurgery, Bern University Hospital	Bern

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic - MITG	Sofradim Production

Country where clinical trial is conducted

Switzerland, 

References & Publications (10)

Borrazzo EC, Belmont MF, Boffa D, Fowler DL. Effect of prosthetic material on adhesion formation after laparoscopic ventral hernia repair in a porcine model. Hernia. 2004 May;8(2):108-12. doi: 10.1007/s10029-003-0181-6. Epub 2003 Nov 21. — View Citation

Carbajo MA, Martp del Olmo JC, Blanco JI, Toledano M, de la Cuesta C, Ferreras C, Vaquero C. Laparoscopic approach to incisional hernia. Surg Endosc. 2003 Jan;17(1):118-22. doi: 10.1007/s00464-002-9079-0. Epub 2002 Oct 29. — View Citation

Chelala E, Gaede F, Douillez V, Dessily M, Alle JL. The suturing concept for laparoscopic mesh fixation in ventral and incisional hernias: preliminary results. Hernia. 2003 Dec;7(4):191-6. doi: 10.1007/s10029-003-0143-z. Epub 2003 Jun 13. — View Citation

Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab. — View Citation

Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998 Apr;133(4):378-82. doi: 10.1001/archsurg.133.4.378. — View Citation

LeBlanc KA. Tack hernia: a new entity. JSLS. 2003 Oct-Dec;7(4):383-7. — View Citation

LeBlanc KA. The critical technical aspects of laparoscopic repair of ventral and incisional hernias. Am Surg. 2001 Aug;67(8):809-12. — View Citation

Schumpelick V, Klinge U. Prosthetic implants for hernia repair. Br J Surg. 2003 Dec;90(12):1457-8. doi: 10.1002/bjs.4385. No abstract available. — View Citation

van't Riet M, de Vos van Steenwijk PJ, Kleinrensink GJ, Steyerberg EW, Bonjer HJ. Tensile strength of mesh fixation methods in laparoscopic incisional hernia repair. Surg Endosc. 2002 Dec;16(12):1713-6. doi: 10.1007/s00464-001-9202-7. Epub 2002 Jul 8. — View Citation

Winslow ER, Diaz S, Desai K, Meininger T, Soper NJ, Klingensmith ME. Laparoscopic incisional hernia repair in a porcine model: what do transfixion sutures add? Surg Endosc. 2004 Mar;18(3):529-35. doi: 10.1007/s00464-003-8519-9. Epub 2004 Feb 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mesh shrinkage		perioperative, 6 weeks, 6 months postoperative
Secondary	mesh dislocation		perioperative, 6 weeks postoperative,6 months postoperative
Secondary	pain		perioperative, 6 weeks postoperative,6 months, 12 moths postoperative
Secondary	recurrence		perioperative, 6 weeks postoperative,6 months, 12 months postoperative